If you recall, a network member told us that she is working on an SOP revision for Autologous Blood Donation (Auto) orders. Her facility currently uses the computer system SafeTrace plus, which requires a paper trail for tracking purposes. However, her facility has not required WRITTEN doctor's orders for initiating an autologous blood donation since approximately 1996. Rather, her institution takes verbal or FAXed authorizations from the doctors. These authorizations may come directly from the medical staff or from office personnel via the phone, as well as faxed and written orders. A friend of the inquiring member (who used to work for the Red Cross) states that she remembers that the Red Cross required that a verbal or FAXed Auto order had to be followed by a written order with a physician's signature. The inquiring member asks if anyone is aware that it is a requirement of FDA, AABB, CAP, or any other organization (other than possibly Red Cross), to mandate a physician's signature for processing an autologous blood donation? The inquiring member would be grateful to know if a physician signature authorizing an Auto order is truly required by regulation as she completes her SOP revision.

To which the following responses were received. Please note that some institutions/individuals use a very conservative interpretation of the published rules and regulations. I believe that the following discussions itemize the applicable rules and regs. The reader will need to decide how to apply the following information to their own situation:

1. An administrator at a major blood collection organization wrote that his personnel were not aware of any FDA or AABB requirement that specifically required an ordering physician's signature to be obtained in order to initiate an autologous donation. This administrator pointed out that AABB Standard 5.4.3.1 states that "blood collection from donor-patients requires the order of the donor-patient's physician and the agreement of the medical director." However, the administrator also points out that the Standard provides no details on what form the order must take. Nor does the Standard state that the actual signature of the ordering physician is required. This administrator's blood center SOP permits a copy of the autologous blood order to be submitted by FAX. The SOP also allows for the first unit to be drawn based on a telephone order, but written authorization must be obtained prior to collecting a 2nd or subsequent unit. The phone order is permitted if all "options to obtain written authorization from the donor's MD have been exhausted."

2. A pathologist responded that the AABB Technical Manual stipulates that although the patient's physician initiates the request for autologous transfusion, it is the responsibility of the Medical Director of the Transfusion service to ensure the health and safety of the procedure vis a vis the patient. This pathologist went on to say that the Technical Manual also stipulates that the request for autologous collection must be made in writing by the patient's physician following the usual identification requirements, and that this request must be signed by the requesting physician. Web Master's NOTE: While it is true that the AABB Technical Manual is often quoted, it is important to remember that this book is NOT a regulatory document. The Technical Manual may help define community practices, but it does NOT "mandate" practice with the force or authority of a true regulation or law.

3. A technologist in Southern California said that based on her personal experiences at her facility, a written order signed by a physician was required to initiate an autologous donation. She did not think that it was OK to have an RN write in a physician's name and counter initial the order. She was also concerned that there might be a CLIA requirement that such orders be signed by a physician, and that failure to comply could result in an audit by "Medicare fraud people", if the cost of testing or collecting autologous blood was billed to Medicare. This member's facility had been cited on a California Biologics inspection for not having written physician orders for all of their autologous collections. Finally, this member's interpretation is that FAXed orders signed by an MD are acceptable documentation, and that if you have a computerized ordering system that requires an MD to LOGON to the system with a password, that an order to initiate an autologous donation could be placed electronically to the blood bank or donor center via the computer system.

4. A compliance officer at a prestigious university institution that favors blue and gold stated that according to AABB Standard 5.4.3.1: "Blood collection from donor-patients requires the order of the donor-patient's physician and the agreement of the medical director". In addition, this compliance officer added that according to 42CFR493:1105: "The laboratory must perform tests only at the written or electronic request of an authorized person. Oral requests for laboratory tests are permitted only if the laboratory subsequently requests written authorization for testing within 30 days. The laboratory must maintain the written authorization or documentation of efforts made to obtain a written authorization". Also, she indicated that JCAHO requires that:

• under QC5.1: Written policies and procedures for the blood bank service conform to the current edition of the AABB Standards for Blood Banks and Transfusion Services, are readily available
• under IM7.2: All requests for laboratory tests are made in writing or through electronic means; oral requests are permitted only if the laboratory obtains written authorization for testing in accordance within its own policy, but within 30 days.
• under IM7.3: The laboratory performs tests and examines specimens upon the written or electronic request of authorized individuals ... in accordance with applicable law regarding ordering tests or receiving tests.

Editor's NOTE: The compliance officer wanted to know if the network membership appreciates that according to JCAHO in QC5.1 -- BB policies and procedures shall conform to AABB Standards. The compliance officer believes that JCAHO is now requiring compliance with AABB Standards, much the same way that the State of California codifies the AABB Standards as law. It will be interesting to hear what the AABB thinks about this.

5. Another member indicated that at his institution, they require a faxed or written autologous order with the physician's signature on it. They do not take verbal autologous orders.

6. Another member reported that the answer to this network discussion resides in the CAP Laboratory General Checklist, which reads:

QUESTION:
01:40930 PHASE I: Does the laboratory have a mechanism to ensure that specimens are analyzed only at the request of an authorized healthcare provider? NOTE: The laboratory must perform tests only at the written or electronic request of an authorized person. For laboratories subject to CLIA-88 regulations, verbal requests for laboratory tests are permitted only if the laboratory subsequently obtains written authorization for testing within 30 days. The laboratory must maintain the written authorization or documentation of efforts made to obtain a written authorization. In a managed office where the staff assistants are not employees of the physician/clinician, the staff should not sign a test requisition for the physician without some type of provider services agreement. This agreement must specify how the clinician has accepted responsibility for the tests ordered from the off-site laboratory. This often differs from the hospital environment, where the physician has personally signed the order sheet. In some U.S. states and other countries, individuals may order some laboratory tests without a physician's referral (direct-access testing).

REFERENCES:
1) Department of Health and Human Services, Health Care Financing Administration. Clinical laboratory improvement amendments of 1988; final rule. Federal Register. 1992(Feb 28):7162 [42CFR493.1105]; 
2) Shulze. Microscope on Washington. Direct-access testing: a state-by-state analysis. Lab Med. 1999;30:371-373; 3) Valenstein P, Meier F. Outpatient order accuracy. A College of American Pathologists Q-Probes study of requisition order entry accuracy in 660 institutions. Arch Pathol Lab Med. 1999;123:1145-1150.

7. Another member wrote that in her hospital, ALL ORDERS (verbal or otherwise) must be signed by the ordering physician within 24 hours. However, in certain areas, they do have verified electronic signatures which take the place of actual written signatures but have to be actually entered by the physician (not a PA, secretary, etc.).

ADDENDUM April 2, 2001

8. The practice of medicine is regulated by the individual states, NOT by the AABB, FDA, JCAHO, CAP or CLIA. State laws usually require that ordering laboratory tests and the prescription of biologics, drugs, etc. (which usually includes "therapeutic" phlebotomy and blood transfusion) require a physician's order, or that of an appropriately credentialed non-physician practitioner for some drugs and laboratory tests.. Check your state laws for what constitutes a legitimate physician's order and whether it needs to be written. In New York State, it does.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator